All posts Tag / FDA
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Accelerating FDA Approval with MIDD: How A2-Ai Secured a New Dose Without a Phase 3 Trial

Eric Storms November 14, 2025
The future of MIDD - How are you preparing? The FDA has officially announced their roadmap to phase out animal testing for monoclonal antibodies. How are you preparing? When your regulatory and operational questions inevitably arise, our experts will be there to answer them every step of the way. Jack Cook SVP, Clinical Pharmacology • 30+ years at Pfizer • 35+ years in pharmaceutical sciences • MIDD leader Linh Nguyen EVP, Clinical Pharmacology • 20+ years in Drug Development • Modeling and Clinical Pharmacology leader • Amgen, Exelixis, Medivation, Pfizer, Arcus, and Treadwell Limitations of Animal Testing: • Safety signals - extremely difficult to translate in animals to men for biologics • Variability in immune architecture can obscure translatability • Interspecies differences cause limitations in predicting human toxicity "more effective, human-relevant methods" AI-based computational models Mimic human cognition to analyze data and measure toxicity within a drug - Reliably predict side-effects and the drugs mollecular composition Humanoids/Organoids Mimic human organs, such as the liver, heart, and immune organs to test drug safety Reveals toxic effects that could easily be undetected in animals Real-world Human Data Using Safety data from countries with similar regulatory standards where the drugs with similar targets have already undergone human studies
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MIDD - FDA Has Officially Announced Their Roadmap to Phase Out Animal Testing for Monoclonal Antibodies

Simonne Bruck April 30, 2025
Did you know... A2-Ai supports IND filling? Investigational New Drug (IND) Services: A2-Ai offers expert guidance on IND write-ups, justification, strategy, and development. IND applications are a critical piece of the drug development process and serve as the key gateway from preclinical to clinical research. We will assist you through the application process to help smooth the pathway to FDA approval. The A2-Ai team is available for writing the pre-IND Briefing and IND Document as well as attending the pre-IND meeting with the FDA to defend the dose escalation strategy, study designs, and clinical pharmacology plans Our philosophy: Results on time, on budget. By combining deep technical expertise with agile methodologies, A2-Ai delivers fast, impactful results that drive accurate study conclusions. By focusing on efficiency and smart resource allocation, we provide key results without exceeding budgets, ensuring clients get the most out of their investment. A2-Ai is budget-conscious, delivering high-quality technological solutions that maximize value while minimizing your costs. Preclinical Support: We will design preclinical PK/Tox/Pharmacology studies/ Design your First in Human (FIH) study as a part of the IND package and write IND modules, IB and study protocol. Pharmacometrics: Preclinical PK/PD modelling and simulation to support Dose/Schedule Selection Advanced mathematical and statistical support Clinical Pharmacology: We will draft the Pre-IND Briefing Document, and if needed will attend regulatory meetings to defend the company's position and answer the agency's questions. Education: Hands-on mentorship and educational training Access to our world-class expertise in both pharmacometrics and in instruction to help your team members grow Technology A2-Ai Cloud: scalable, secure computing environment - enabling faster analysis, easier collaboration, and all the reproducibility and traceability requirements needed in both experimental and GxP compliant contexts
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IND Services - We Support and Assist You in IND Applications to Streamline the FDA Approval Process

Simonne Bruck February 28, 2025